Abstract

ObjectiveQuality of life data in cancerology are often difficult to summarize due to missing data and difficulty to analyze the pattern of evolution in different groups of patients. The aim of this work was to apply a new methodology to construct Quality of Life (QoL) change patterns within patients included in a clinical trial comparing to regimen of treatment in locally advanced eosogastric cancer.Materials and methodsIn this trial, QoL was assessed every 2 months by self-reported EORTC QLQ-C30 questionnaire. Physical dimension scores were analyzed. After multiple imputation of missing data, 27 statistical measures aiming to describe the variation of QoL measures among follow-up were computed for each patient. Based on these measures, patient were grouped into homogenous groups in terms of QoL variation pattern using a K-Means classification method. The mean QoL score at each time was graphically represented in each obtained pattern. Finally, clinical characteristic of patients in each pattern of QoL were described and compared.ResultsThe trial included 416 patients and 1023 questionnaire were collected. 74 % of patients were male with a mean ± SD age of 62 ± 11 years. 43 % of scores were missing. Patients were grouped into four classes of homogeneous QoL variation patterns. 1) a Pattern of 24 (6 %) patients showing improvement in QoL with a mean variation of +10.7 points on the 0–100 scale, 2) a Pattern of 171 (41 %) patients showing a stability 3) two Patterns of 78 (19 %) and 143 (34 %) patients respectively showing a deterioration of QoL with a mean variation of −67.2 and −67.6, respectively. There were no difference between patterns in terms of gender or age. Patients within “degradation” pattern had significantly lower performance status (p = 0.015), higher severe after-effects rate (p < 10-3) and death rate (p < 10-3).ConclusionThis work opens up perspectives for longitudinal data analysis with a high probability of missing values while providing a relevant graphical summary. Patterns of QoL evolution with clinical relevance may help to interpret longitudinal QoL data in Cancer studies.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-015-0342-1) contains supplementary material, which is available to authorized users.

Highlights

  • Gastrointestinal cancers are among the most frequent cancers in France [1, 2]

  • Patients were grouped into four classes of homogeneous Quality of Life (QoL) variation patterns. 1) a Pattern of 24 (6 %) patients showing improvement in QoL with a mean variation of +10.7 points on the 0–100 scale, 2) a Pattern of 171 (41 %) patients showing a stability 3) two Patterns of 78 (19 %) and 143 (34 %) patients respectively showing a deterioration of QoL with a mean variation of −67.2 and −67.6, respectively

  • The nature of the association between the probability of missing data and other variables defines the three so-called missing data mechanisms: 1/ A missing completely at random (MCAR) mechanism occurs when the propensity for missing data on a particular variable is unrelated to other measured variables and to the would-be values of that variable, 2/ A missing at random (MAR) mechanism which holds when the probability of missing data on a variable is related to other variables, but not to the would-be values of the incomplete variable, 3/ A missing not at random (MNAR) mechanism that occurs when the probability of missing data on a variable is related to the would-be value of that variable

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Summary

Introduction

Gastrointestinal cancers are among the most frequent cancers in France [1, 2]. Metastatic or locally-advanced cancers have a bleak prognosis. Nuemi et al Health and Quality of Life Outcomes (2015) 13:151 patient Collecting these data currently requires the use of multidimensional measurement scales, each dimension being summarized when possible by a computed score. The reasons for MD are wide and varied, Rubin et al proposed, in a theoretical framework on missing data problems [13], a classification system that is widely used in the methodological literature [14,15,16]. According to this system, whatever the reason for missing data, it can fit into one of the three classes of missing data mechanisms. The impact of MD must be taken into account to attenuate the non-negligible risk of bias [15, 17]

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